Zydena

Erectile dysfunction.

Adult & elderly Initially 100 mg once daily approx 30 min-12 hr before sexual activity, may be increased to 200 mg once daily.

May be taken with or without food.

Hypersensitivity. Men for whom sexual activity is inadvisable due to underlying CV disease. Congenital QT prolongation syndrome; hypotension (BP <90/50 mmHg), uncontrolled HTN (BP >170/100 mmHg) & arrhythmias, stroke, MI or history of CABG w/in last 6 mth, known hereditary degenerative retinal disorders eg, retinitis pigmentosa. Co-administration w/ nitric oxide donors, organic nitrates or nitrites. Concomitant use w/ guanylate cyclase stimulator (eg, riociguat), drugs prolonging QT interval, potent CYP450 3A4 inhibitors (eg, HIV PI indinavir or ritonavir). Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Severe hepatic or renal failure. Childn <18 yr.

Hypersensitivity or history of allergic reaction. Discontinue use if sudden vision or hearing loss or deafness develops. Not to be used as aphrodisiac nor stamina enhancer. Not to be used in patients who had stroke, cerebral hemorrhage or MI w/in last 6 mth. CV status; left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis), severely impaired autonomic BP control; anatomical penis deformation or conditions predisposing to priapism eg, sickle cell anemia, multiple myeloma or leukemia; active GERD or hiatal hernia associated w/ reflux esophagitis; uncontrolled DM, spinal cord injury, radical prostatectomy or pelvic surgery, low sexual desire, chemotherapy; proliferative diabetic retinopathy. Concomitant use w/ nitrate or nitric oxide donor drugs, CYP450 3A4 inhibitors, α-blockers, anticoagulants. May affect ability to drive & use machines. Not recommended in moderate to severe renal impairment. Hepatic or renal failure. Not indicated for use in newborn, childn <18 yr or women.

Flushing. Headache; ocular hyperemia; nasal congestion; dyspepsia.

Increased plasma conc by CYP450 3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir, indinavir, cimetidine, erythromycin, grapefruit juice. Decreased plasma conc by CYP450 3A4 inducers eg, dexamethasone, rifampicin, antiepileptics eg, phenytoin, phenobarb, carbamazepine. Increased heart rate, decreased BP, dizziness, headache & orthostatic symptoms w/ alcohol. Decreased BP w/ nitroglycerine, amlodipine besylate. Symptomatic hypotension w/ α-blockers. Increased C_max & AUC w/ ketoconazole, omeprazole.

Drugs for Erectile Dysfunction & Ejaculatory Disorders

G04BE11 - udenafil ; Belongs to the class of drugs used in erectile dysfunction.

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